LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects With CCR8-Positive Gastric and Gastroesophageal Junction Adenocarcinoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaNova Medicines Limited

About this trial

This is a phase III, Multicenter, Randomized study, evaluating the efficacy and Safety of LM-108(an Anti-CCR8 mAb) in combination With Toripalimab Versus Paclitaxel Injection in subjects with CCR8-Positive locally advanced or metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma.

Eligibility criteria

Qualifiers

Individuals who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.

Age 18 years or older, male or female.

Weight ≥ 40 kg or Body Mass Index (BMI)≥ 18.5 kg/m²

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Disqualifiers

Received treatment targeting the same target or other drugs acting on regulatory T cells (Tregs).

Received antitumor treatments such as chemotherapy, radiotherapy, biological therapy, immunotherapy, or Chinese herbal medicine or Chinese herbal preparations within 2-4 weeks (depending on the specific anticancer drug) prior to the first dose.

Received anti-PD-(L)1 antibody immunotherapy and experienced disease progression confirmed by RECIST 1.1 assessment within ≤2 months after treatment initiation.

Use of any live vaccine within 4 weeks prior to the first dosing of study drugs.

Trial design

Treatments tested in this trial

  • LM-108 in combination with Toripalimab
  • Paclitaxel injection intravenous infusion

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators